Commission Directive 2006/75/EC of 11 September 2006 amending Council Directive 91/414/EEC to include dimoxystrobin as active substance   (Text with EEA relevance)
Date: 2006-09-11
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health control, plant health product

12.9.2006

EN

Official Journal of the European Union

L 248/3

COMMISSION DIRECTIVE 2006/75/EC

of 11 September 2006

amending Council Directive 91/414/EEC to include dimoxystrobin as active substance

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the
market (1), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

In accordance with Article 6(2) of Directive 91/414/EEC
the United Kingdom received on 28 November 2001 an
application from BASF for the inclusion of the active
substance dimoxystrobin in Annex I
to Directive
91/414/EEC. Commission Decision 2002/593/EC (2)
confirmed that the dossier was ‘complete’
in the sense
that it could be considered as satisfying, in principle, the
data and information requirements of Annexes II and III
to Directive 91/414/EEC.

For this active substance, the effects on human health
and the environment have been assessed, in accordance
with the provisions of Article 6(2) and (4) of Directive
91/414/EEC, for the uses proposed by the applicants. The
designated rapporteur Member State submitted draft
assessment
report concerning the substance dimoxy-
strobin to the European Food Safety Authority (EFSA)
on 14 August 2003.

The draft assessment report has been peer reviewed by
the Member States and the EFSA within its Working
Group Evaluation and presented to the Commission on
10 August 2005 in the format of the EFSA Scientific
Report
report has been
reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
Animal Health and finalised on 4 April 2006 in the
format of the Commission review report for dimoxy-
strobin.

for dimoxystrobin (3). This

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2006/74/EC (OJ L 235, 30.8.2006, p. 17).

(2) OJ L 192, 20.7.2002, p. 60.
(3) EFSA Scientific Report (2005) 46, 1-82: conclusion regarding the peer
the active substance

the pesticide risk assessment of

review of
dimoxystrobin (finalised: 10 August 2005).

It has appeared from the various examinations made that
plant protection products containing the active substance
concerned may be expected to satisfy,
in general, the
requirements laid down in Article 5(1)(a) and (b) and
Article 5(3) of Directive 91/414/EEC, in particular with
regard to the uses which were examined and detailed in
the Commission review report. It is therefore appropriate
to include dimoxystrobin in Annex I to that Directive, in
order to ensure that in all Member States the authori-
sations of plant protection products containing this
active substance may be granted in accordance with the
provisions of that Directive.

the

down

requirements

in particular

six months after

in Annex I, Member States

(5) Without prejudice to the obligations defined by Directive
including an active
91/414/EEC as a consequence of
should be
substance
inclusion to
allowed a period of
authorisations of plant
review existing provisional
protection products containing dimoxystrobin to ensure
laid
that
by Directive
in its Article 13 and the
91/414/EEC,
relevant conditions set out
in Annex I, are satisfied.
Member States should transform existing provisional
authorisations into full authorisations, amend them or
withdraw them in accordance with the provisions of
Directive 91/414/EEC. By derogation from the above
deadline, a longer period should be provided for the
submission and assessment of the complete Annex III
dossier of each plant protection product
for each
intended use in accordance with the uniform principles
laid down in Directive 91/414/EEC.

(6)

(7)

is

It
therefore
91/414/EEC accordingly.

appropriate

to

amend Directive

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.

L 248/4

EN

Official Journal of the European Union

12.9.2006

Article 2

1. Member States shall adopt and publish by 31 March 2007
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.

in Annex VI
a dossier

to Directive
uniform principles provided for
91/414/EEC, on the basis of
the
requirements of Annex III to that Directive and taking into
to that Directive
account part B of
the entry in Annex I
that evaluation,
concerning dimoxystrobin. On the basis of
they shall determine whether the product satisfies the conditions
set out
(d) and (e) of Directive
(c),
91/414/EEC.

in Article 4(1)(b),

satisfying

They shall apply those provisions from 1 April 2007.

Following that determination Member States shall:

When Member States adopt those provisions, they shall contain
a reference to this Directive or shall be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing dimoxy-
strobin as active substance by 31 March 2007. By that date,
they shall in particular verify that the conditions in Annex I to
that Directive relating to dimoxystrobin are met, with the
exception of those identified in part B of the entry concerning
those active substances, and that the holder of the authorisation
has, or has access to, a dossier satisfying the requirements of
Annex II to that Directive in accordance with the conditions of
Article 13.

By way of derogation from paragraph 1,

2.
for each
authorised plant protection product containing dimoxystrobin
as either the only active substance or as one of several active
substances all of which were listed in Annex I to Directive
91/414/EEC by 30 September 2006 at
the latest, Member
in accordance with the
States shall re-evaluate the product

(a)

in the case of a product containing dimoxystrobin as the
only active substance, where necessary, amend or withdraw
the authorisation by 31 March 2008 at the latest; or

active

substances, where necessary,

(b) in the case of a product containing dimoxystrobin as one of
several
amend or
withdraw the authorisation by 31 March 2008 or by the
date fixed for such an amendment or withdrawal
in the
respective Directive or Directives which added the relevant
substance
to Directive
91/414/EEC, whichever is the latest.

to Annex

substances

or

I

Article 4

This Directive shall enter into force on 1 October 2006.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 11 September 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

12.9.2006

EN

Official Journal of the European Union

L 248/5

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